Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
NCT06980688

The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability

Led by University Hospital, Basel, Switzerland · Updated on 2025-09-19

320

Participants Needed

4

Research Sites

104 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Basel, Switzerland

Lead Sponsor

U

University of Basel

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of this multicentre, single-blinded, expertise-based randomised controlled trial is evaluate whether slowly increasing the dose of the anaesthetic drug propofol based on a patient's needs leads to more stable blood pressure compared to giving a standard starting dose in patients aged 55 and older undergoing non-cardiac surgery.

CONDITIONS

Official Title

The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 55 years old or older
  • Scheduled for planned non-cardiac surgery under general anaesthesia with intubation including ear, nose and throat, gynaecological, maxillofacial, orthopedic, plastic and reconstructive, spine, urologic, vascular, and visceral surgeries
  • Use of propofol Target-Controlled Infusion (TCI) with the Schnider model and remifentanil TCI with the Minto model for anaesthesia
  • American Society of Anesthesiologists Physical Status Classification I-IV
  • Body mass index (BMI) of 18.5 to less than 35 kg/m2
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Awake tracheal intubation or rapid sequence induction
  • Combined general and regional anaesthesia procedures
  • Opioid-free anaesthesia or opioid-sparing modifications using lidocaine, magnesium, ketamine, clonidine, or dexmedetomidine
  • Surgery performed in prone position within the first 30 minutes
  • Known difficult airway
  • Daily alcohol consumption over one unit or more than seven units per week
  • Regular recreational drug abuse
  • Chronic use of benzodiazepines or opioids
  • Allergy to propofol
  • Known brain pathologies including seizure disorders, stroke within past 9 months, or dementia
  • History of awareness during anaesthesia
  • Inability to follow procedures or insufficient knowledge of German language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Kantonsspital Baden

Baden, Switzerland, 5404

Not Yet Recruiting

2

University Hospital Basel

Basel, Switzerland, 4031

Actively Recruiting

3

Cantonal Hospital Graubünden

Chur, Switzerland, 7000

Not Yet Recruiting

4

Kantonsspital Olten, soH

Olten, Switzerland, 4600

Not Yet Recruiting

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Research Team

M

Martin Lohri, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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